挤压器联动装置制备两性霉素B脂质体

Preparation of Liposome Amphotericin B by Using Extruding Linkage Device

目的考察挤压器联动装置制备两性霉素B脂质体制剂的稳定性。方法使用联动装置制备两性霉素B脂质体,用透析法检测两性霉素B脂质体的药物包封率,粒径仪器跟踪脂质体制剂的粒径及其分布,测定稳定性、泄漏率及毒性。结果所用联动装置可使脂质体的制备工艺简化,投料成品一步完成,同时可在线监控粒径。采用此装置制备的两性霉素B脂质体的粒径显著小于手动方式所制备,且粒径分布较窄;药物包封率为97.3%。通过与手动方法制备的脂质体制剂的多项技术指标对比,表明采用联动装置制备的两性霉素B脂质体制剂的药物包封率高,制剂稳定性好,药物渗漏率低。结论挤压器联动装置可用于工业化生产两性霉素B脂质体制剂的产品质量稳定、可控。

Objective To study the stability of the liposomal amphotericin B preparation by extruding linkage device. Methods The liposomal amphotericin B was prepared by extruding linkage device. The quality and stability of liposomal amphotericin B were investigated. The encapsulation ratio of amphotericin B in liposomes was detected by method of dialysis. The particle size of liposomal amphoteriein B was detected by PSS NICOMP 380 systems. Results The extruding linkage device facilitated the preparation of liposomes with a one- step from charging material to preparing final liposomal products. The linkage production line was suitable for the preparation of amphotericin B. The particle size of liposomal amphotericin B prepared by this device was significantly smaller that by the manual method with more narrow distribution, and encapsulation rate was 97.3% respectively. By contrast with specification of liposomal amphotericin B preparation with different methods showed that the application of the extruding linkage device preparation amphotericin B had high drug encapsulation efficiency, good stability and the low rate of drug leakage. Conclusion This linkage device can be applied to industrialize the liposome preparation with advantages of convenient technique, well- controlled and practical orientation.